Judge Orders FDA to Speed Up Release of Covid Vaccine Trial Data From 23.5 Years to Just 2

A federal judge in Texas this week ordered the Food and Drug Administration (FDA) to make public data it relied on to license COVID-19 vaccines—Moderna’s for adults and Pfizer’s for children—at an accelerated rate, requiring all documents to be made public by mid-2025 rather than, as the FDA wanted, over the course of around 23.5 years.

In a decision hailed as a win for transparency by the lawyer representing the plaintiffs (the parents of a child injured by a COVID-19 vaccine) in a lawsuit (pdf) against the FDA, the Texas judge ordered the FDA to produce the data about ten times faster than the agency wanted.

“Democracy dies behind closed doors,” is how U.S. District Judge Mark Pittman opened his order (pdf), issued on May 9, which requires the FDA to produce the data on Moderna’s and Pfizer’s COVID-19 vaccines at an average rate of at least 180,000 pages per month.

The FDA had argued it would be “impractical” to release the estimated 4.8 million pages at more than between 1,000 and 16,000 pages per month, which would have taken at least 23.5 years.

Aaron Siri of Siri & Glimstad, who represents the plaintiffs in the legal action against the FDA, called the decision “another blow for transparency and accountability” that builds on an earlier court order targeting Pfizer’s COVID-19 vaccine data for those aged 16 and older.

The January 2022 order (pdf), also issued by Pittman, forced the FDA to produce all its data on Pfizer’s COVID-19 vaccine for those aged 16 and older at a rate of 55,000 pages per month, or much faster than the 75 years the agency had sought.

“That production should be completed in a few more months,” Siri said in a statement, referring to the earlier Pfizer data for those aged 16 and up.

The latest order requires the FDA to produce all of its data on Pfizer’s COVID-19 vaccine for 12- to 15-year-olds (and Moderna’s product for adults) by June 31, 2025.

‘Stale Information Is of Little Value’

While the judge noted in his order that the court recognizes the FDA’s limited resources dedicated to freedom of information requests (FOIA), he argued that “the number of resources an agency dedicates to such requests does not dictate the bounds of an individual’s FOIA rights.”

“Instead, the Court must ensure that the fullest possible disclosure of the information sought is timely provided—as ‘stale information is of little value,’” Pittman wrote.

In order to ensure the FDA can meet the accelerated deadline—so around ten times faster than the agency wanted—the judge ordered the parties to the lawsuit to confer and submit a joint production schedule for the data by May 23, 2023.

In the earlier case adjudicated by Pittman, the FDA had argued it only had the bandwidth to review and release around 500 pages per month of an estimated total 450,000 pages of material about the Pfizer COVID-19 vaccine for those aged 16 and older.

The FDA has not disputed in either case that it has an obligation to make the information public but it has argued that its short-staffed FOIA office could not meet the pace of production sought by the plaintiffs.

The judge disagreed, arguing in both cases that the imperatives of transparency and accountability are of paramount importance.

In the January order, Pittman said that too much foot-dragging and secrecy on the part of federal agencies feeds conspiracy theories and reduces the public’s trust in government.

Confidence in the FDA over COVID-19 vaccine approvals was shaken by the disclosure that regulators sped up the approval of Pfizer’s vaccine.

Republicans on the House Select Subcommittee on the Coronavirus Pandemic in March announced they were seeking answers after recently released emails indicated that the FDA rushed the approval of COVID-19 vaccines and boosters to accommodate vaccine mandates.